alexa Interference-Free HER2 ECD as a Serum Biomarker in Brea

Journal of Molecular Biomarkers & Diagnosis
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Research Article

Interference-Free HER2 ECD as a Serum Biomarker in Breast Cancer

Lian Lam1, Brian J. Czerniecki2, Elizabeth Fitzpatrick2, Shuwen Xu2, Lynn Schuchter3, Xiaowei Xu1 and Hongtao Zhang1*

1Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, U.S.A

2Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, U.S.A

3Division of Hematology-Oncology, HUP, 16 Penn Tower, Philadelphia, U.S.A

*Corresponding Author:
Hongtao Zhang
Department of Pathology and Laboratory Medicine
Perelman School of Medicine, University of Pennsylvania
252 John Morgan Building, 3620 Hamilton Walk
Philadelphia, PA 19104-6082, U.S.A
Tel: 215-573- 9256
Fax: 215-898-2401
Email: [email protected]

Received date: October 07, 2013; Accepted date: November 11, 2013; Published date: November 14, 2013

Citation: Lam L, Czerniecki BJ, Fitzpatrick E, Xu S, Schuchter L, et al. (2013) Interference-Free HER2 ECD as a Serum Biomarker in Breast Cancer. J Mol Biomark Diagn 4:151. doi:10.4172/2155-9929.1000151

Copyright: © 2013 Lam L, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited



Over-expression of the HER2/neu receptor occurs in 20 to 30 percent of breast tumors and is linked to poorer prognosis. The HER2/neu expression status determines whether or not patient will receive trastuzumab- based treatment. In clinical practice, over-expression of HER2/neu is routinely identified using Immunohistochemistry (IHC) or Fluorescence in Situ Hybridization (FISH), both of which are invasive approaches requiring tissue samples. Serum assays for the Extra Cellular Domain of HER2/neu receptor (HER2 ECD) have been reported but the use is very limited due to serum interference factors (e.g. human anti-animal immunoglobulin antibodies) that lead to false test results and inconsistency with tissue Her2 status. We have developed an ELISA based approach using an MBB buffer to eliminate false results and to obtain more accurate assessment of HER2 ECD levels. Using this refined assay we retroactively measured HER2/neu levels from breast cancer patients and controls. Abnormal HER2 ECD levels were detected in about 32% of invasive breast cancer patients but not in controls or patients with benign diseases. In addition, we also showed that patients with elevated serum HER2 levels appeared to have worse survival regardless of treatments. In a small group of 12 Ductal Carcinoma in situ (DCIS) patients who received HER2/neu peptide vaccination and surgery, only one patient showed constantly rising HER2 levels after treatment and this patient had recurrence of HER2 positive tumor within 5 years. Our studies indicate that once the serum interference issue is resolved, serum HER2 ECD can have potential clinical utility to supplement the tissue based tests.

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